Vision after Clareon PanOptix versus another multifocal intraocular lens
Visual Performance Differences Between Clareon PanOptix and a Comparable Multifocal Intraocular Lens
This study will test whether people having cataract surgery have better vision and satisfaction with the Clareon PanOptix lens compared with another multifocal lens.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Sex | All |
| Sponsor | Argus Research Center, Inc. Academic / other |
| Locations | 3 sites (Torrance, California and 2 other locations) |
| Trial ID | NCT07006428 on ClinicalTrials.gov |
What this trial studies
This two-part, multicenter, investigator-initiated study compares visual outcomes and patient satisfaction after bilateral implantation of the Clareon PanOptix (or PanOptix Toric) versus a comparable multifocal intraocular lens. The first pilot phase includes retrospective and prospective data from patients 2.5–5 months after implantation, while the second phase is a prospective, randomized comparison of planned bilateral femtosecond laser-assisted cataract surgery with bilateral IOL implantation. Key outcomes include distance, intermediate and near visual acuity and patient-reported satisfaction. The study is conducted at three community ophthalmology sites in the United States.
Who should consider this trial
Good fit: Ideal candidates are adults with bilateral age-related cataracts who either already have bilateral Clareon PanOptix or comparable multifocal IOLs implanted (for the pilot phase) or are planning bilateral femtosecond laser-assisted cataract surgery with bilateral Clareon PanOptix or comparable multifocal IOL implantation (for the comparison phase).
Not a fit: Patients with significant ocular comorbidities, poor preoperative visual potential, unilateral cataract, or who are not targeted for emmetropia are unlikely to experience benefit from participation.
Why it matters
Potential benefit: If successful, the study could identify which multifocal IOL provides better overall vision and higher patient satisfaction after cataract surgery.
How similar studies have performed: Previous studies comparing multifocal intraocular lenses, including published results for PanOptix, have shown improvements in range of vision and patient satisfaction, so this approach has precedent.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Stage 1: IIT Pilot * Willing and able to understand and sign informed consent. * Adult patients previously diagnosed with age-related cataracts bilaterally. * Previous bilateral age-related cataract removal and with bilateral implantation of the Clareon PanOptix/ Clareon PanOptix Toric (T3-T4) or Comparable Multifocal Intraocular Lens (equivalent to T3-T4) closest to 2.5-5-months after implantation and \>2 weeks post YAG (if done) that were targeted for emmetropia. * Best monocular corrected distance visual acuity was expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes pre-operatively as determined by surgeon. * Normal ocular findings aside from cataract. Stage 2: Comparison * Willing and able to understand and sign informed consent. * Adult patient diagnosed with age-related cataracts bilaterally. * Planned bilateral cataract removal by femtosecond laser-assisted phacoemulsification with bilateral implantation of the Clareon PanOptix/Clareon PanOptix Toric (T3-T4) or Comparable Multifocal Intraocular Lens (equivalent to T3-T4). * Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively as determined by surgeon. * Residual astigmatism expected to be ≤ 0.50 diopters in both eyes postoperatively as determined by surgeon (after using either toric IOL or arcuate incision with laser). * Normal ocular findings aside from cataract. Exclusion Criteria: Stage 1: IIT Pilot * Corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases, diabetic retinopathy that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation. * Previous history of any ocular surgery including corneal refractive surgery. * Participation in another clinical study that could interfere with the results. * Patients with monovision correction. * Any active ocular infection or inflammation. Stage 2: Comparison * Corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative * diseases that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation. * Previous history of any ocular surgery including corneal refractive surgery. * Participants desiring monovision. * History of amblyopia or monofixation syndrome with poor stereoscopic vision. * Total corneal HOA greater than 0.6um, coma less than 0.3um at 4mm-5mm scan depending on pre- op photopic topography. * Any planned simultaneous/combined procedures at time of cataract surgery (e.g. MIGs). * Participation in another clinical study that could interfere with the results. * Any active ocular infection or inflammation.
Where this trial is running
Torrance, California and 2 other locations
- Wolstan & Goldberg Eye Associates — Torrance, California, United States (Recruiting)
- Tyson Eye — Cape Coral, Florida, United States (Recruiting)
- North Georgia Eye Associates — Gainesville, Georgia, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.